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Can you print surgical guides in a dental lab? I think you can't as it is a medical device as per the FDA definition even you you have the proper resin and printer. Please correct me if I'm wrong. Do labs print surgical guides? How do labs print surgical guides considering that the medical device regulation requires that any medical device has to be manufactured in an FDA approved facility? I've been scratching my head about this issue. (ps I own a small lab and want to print surgical guides).Any resin that goes into the mouth has to be cleared by the FDA for use. Some classifications are for less than 10 minutes in the mouth (custom trays, guides). The other classification is for anything over that time (dentures, temps, crowns, nightguards, etc).
You can’t just print any resin for use in the mouth or you will be sued for every penny if either a patient, doctor or regulatory body finds out. For printing modes use whatever works but for use in the mouth it has to be a Class lla medical device and your printer and curebox have to be validated for use with that resin. That’s why I stated earlier Keystone does a fantastic job of listing every printer and curebox that works (validated) with their resin.